An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Systemic Sclerosis

• Status: Not yet recruiting
• Trial end date: 2023-10-31
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy of nemolizumab in systemic sclerosis patients. To evaluate also the safety and pharmacokinetics.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maruho Co., Ltd.

Criteria

Inclusion Criteria:

• Diagnosis of Systemic Sclerosis according to American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) 2013 criteria

• Systemic Sclerosis patients with moderate to sever skin sclerosis

Exclusion Criteria:

• Patients witg a disease considered inappropriate for participation in clinical trials, such as serious cardiac / hepatic / renal / pulmonary / hematologic disease

• Patients with a diseases that could interfere with assessment of Systemic Scleorosis

• Patients with body weight less than 30.0kg

• Pregnant or lactating women.